The following data is part of a premarket notification filed by Spirox, Inc. with the FDA for Spirox Inex Device.
Device ID | K132920 |
510k Number | K132920 |
Device Name: | SPIROX INEX DEVICE |
Classification | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
Applicant | SPIROX, INC. 381 ARLINGTON WAY Menlo Park, CA 94025 |
Contact | Mike Rosenthal |
Correspondent | Mike Rosenthal SPIROX, INC. 381 ARLINGTON WAY Menlo Park, CA 94025 |
Product Code | NHB |
CFR Regulation Number | 874.3620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-17 |
Decision Date | 2014-06-10 |
Summary: | summary |